ACTRN12610000361000
Recruiting
Phase 4
An unblinded randomised study to evaluate viral resistance (viral shredding) following standard and extended duration Oseltamivir treatment in patients with influenza A/H1N1 2009
Roche Products NZ Ltd0 sites125 target enrollmentMay 6, 2010
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Roche Products NZ Ltd
- Enrollment
- 125
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and non\-pregnant female subjects age greater than or equal to 5 years:
- •2\. A positive Influenza A Rapid Antigen Test (RAT) performed on an adequate nasopharyngeal specimen, in accordance with the manufacturer’s instructions. If the RAT is negative but, in the investigator’s opinion, there is strong clinical suspicion of any type of influenza then the subject may be enrolled.
- •3\. Presence of fever at the time of screening of greater or equal to 37\.8 degrees celius (greater or equal to 100\.04 degrees F) taken orally. A subject self\-report of a history of a fever or feverishness within the 24 hours prior to screening will also qualify for enrolment in the absence of documented fever at the time of screening.
- •4\. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms).
- •5\. Onset of symptoms no more than 48 hours before presentation for screening.
- •6\. Female of non\-childbearing potential, either surgically sterilised or at least one year post\-menopausal. If a female is of childbearing potential, she must be abstinent or using adequate contraceptive precautions, including but not limited to the following: barrier methods (condom or diaphragm), intrauterine contraceptive device (IUCD), oral contraceptive, or equivalent hormonal contraceptive (e.g. progesterone\-only implant, cutaneous hormonal patch, injectable contraceptives) and agree to continue such precautions for the duration of the study.
- •7\. Written informed consent.
Exclusion Criteria
- •1\. Women who are pregnant or breast\-feeding.
- •2\. Presence of clinically significant signs of acute respiratory distress
- •3\. History of severe chronic obstructive pulmonary disease (COPD).
- •4\. History of heart failure of angina requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
- •5\. History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance \<50mL/min).
- •6\. Clinical evidence of worsening of any chronic medical condition (temporarily associated with the onset of symptoms of influenza) which, in the investigator’s opinion, indicated that such finding(s) could represent complications of influenza.
- •7\. Current clinical evidence, including clinical signs and/or symptoms consistent with otitis, bronchitis, sinusitis and/or pneumonia, or active bacterial infection at any body site that requires therapy with oral or systemic antibiotics.
- •8\. Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with \>10 mg prednisone or equivalent on a daily basis within 30 days of screening.
- •9\. Currently receiving treatment for viral hepatitis B or viral hepatitis C.
- •10\. Presence of known Human immunodeficiency virus (HIV).
Outcomes
Primary Outcomes
Not specified
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